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analytical methods for the quality standardization of the herbal medicine Janova, an anestrous treatment

Background: The aim of the present study was to standardize Janova by two biomarkers Piperine and Gingerol-6 present in the herbs used for formulation by adopting sophisticated instruments High performance liquid chromatography and High performance thin layer chromatography methods. Janova is a very effective Ayurvedic polyherbal medicine used to treat anoestrus, one of the most common causes of infertility in cattle. Ingredients of commercial herbal medicines are assessed for quality primarily to ensure their safety. Janova contains four herbs including Zingiber officinale, Piper nigrum and Piper longum. Methods: High performance liquid chromatography (HPLC) and High performance thin layer chromatographic (HPTLC) methods were prepared for the standardization of the Janova with respect to the biomarker compounds Gingerol-6 and Piperine of respective herbs. The developed methods were validated on parameters including linearity, selectivity, precision, recovery, LOD and LOQ in accordance with the statistical method of validation given in ICHQ2R1. Results: Methods developed were being successfully applied in identification and quantification of phytotherapeutic constituents. The average recovery of (Gingerol-6) 99.47 % and (Piperine) 98.20 % were computed from regression equation. RSD for inter-day and intra-day variability were also found to be less than 1%. Conclusion: The outcome of the present investigation underlines the importance of standardization of Ayurvedic formulations and how overall phytochemical consistency of herbal medicines is pivotal to their efficacy. Establishment of harmonized multilaboratory-validated analytical methods developed may be further used to standardize other formulation containing Zingiber officinale, Piper nigrum and Piper longum.